Inhaled salbutamol in elective caesarean sectio

Phase 1

• Conditions: eonatal pulmonary adaptation; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001912-53-FI
• Lead Sponsor: Children's Hospital, Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

The study population consists of 62 healthy singleton newborn infants delivered by elective cesarean section at 37 + 0 to 41+6 gestational weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range: 62
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) clinically significant congenital malformations, 2) birth weight < 2000 grams, 3) intubation, 4) heart rate > 200 bp for more than 5 min, 5) relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids and 6) the suspicion of/confirmed pneumothorax or infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate whether the respiratory status, measured by a transthoracal ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.;Secondary Objective: To study whether infants at risk of developing transient tachypnea of the newborn can be identified early using a transthoracal ultrasound method.;Primary end point(s): Lung compliance and Ultrasound measurements at 3-6 hours of age.;Timepoint(s) of evaluation of this end point: 3-6 hours of age

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: No time for this end point